Struggling With Adoption, Sickle Cell Gene Therapy Manufacturers Embrace CMS Model

  • Dec 12, 2024

    Manufacturers of two high-cost gene therapies for sickle cell disease recently agreed to participate in CMS’s Cell and Gene Therapy Access Model, which is set to launch next year. The deals could allow the companies to more widely market their treatments and improve access for Medicaid beneficiaries, although it remains to be seen how many states will choose to participate in the voluntary model. 

    CMS said in a Dec. 4 press release that it is seeking to have state Medicaid agencies join the model via an application process that runs through the end of February. The agency will then strike outcomes-based agreements (OBAs) with Vertex Pharmaceuticals Inc. and CRISPR Therapeutics, the manufacturers of Casgevy (exagamglogene autotemcel), and Bluebird Bio Inc., the manufacturer of Lyfgenia (lovotibeglogene autotemcel). Casgevy and Lyfgenia were both approved on Dec. 8, 2023, to treat sickle cell disease, a genetic blood disorder that is primarily found in Black people. States that choose to participate have until Jan. 1, 2026, to implement the model, which will run for six years. Patients will be followed for five years to track outcomes. 

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  • Tim Casey

    Tim has been a reporter and editor for newspapers, websites and magazines for more than 20 years, including 10 years covering health care business topics. He has a deep knowledge of the managed care industry and pharmacy benefit management. He also has experience covering medical conferences and clinical and legislative health care issues. In 2014, the Society for Advancing Business Editing and Writing selected Tim as one of 15 journalists to participate in a national symposium on the Affordable Care Act. Tim has a B.A. in Psychology from the University of Notre Dame and an M.B.A. from Georgetown University.

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